The Department of Biotechnology (DBT) launched and validated two indigenous HPV test kits- Truenat HPV-HR Plus and Patho Detect. The RT-PCR-based kits are supported by BIRAC, Grand Challenges India and DBT, and coordinated by AIIMS Delhi with WHO-IARC collaboration. These are designed for affordable, decentralized, point-of-care screening and align with national and WHO cervical cancer elimination goals.
Key Highlights
- Validation Programme: “Validating Indigenous HPV Tests for Cervical Cancer Screening in India”.
- Kits Evaluated: Truenat HPV-HR Plus by Molbio Diagnostics (Goa) and Patho Detect by Mylab Discovery Solutions (Pune)
- Technology: Chip-based real-time PCR (RT-PCR) enabling rapid, accurate results suitable for decentralized/point-of-care use.
- Genotype Coverage: Detects eight high-risk HPV types—including HPV 52 & 58 prevalent in India/Asia. These HPV types are responsible for over 96% of cervical cancer cases globally.
- Cost-Effectiveness: Focuses on 7–8 most common oncogenic HPV types to reduce assay complexity and cost, making large-scale screening feasible in resource-limited and rural settings.
- Alignment with Policy: Supports India’s National Cancer Control Programme and WHO’s cervical cancer elimination strategy (screen 70% of eligible women twice—at ages 35 and 45—by 2030).
- Post-COVID Leverage: Leverages expanded RT-PCR infrastructure established during COVID-19 pandemic to scale up screening beyond classical HPV DNA tests and Pap smears.
Background
What is HPV?
- It is a common viral infection transmitted predominantly through sexual contact. While most HPV types are benign, high-risk strains can lead to cancers (cervical, oropharyngeal, etc.). According to WHO, nearly all sexually active individuals acquire HPV at some point.
Cervical Cancer in India:
- India accounts for ~25% of global cervical cancer cases.
- Annually, ~1.23 lakh new cases and ~77,000 deaths.
- It is second most common cancer among Indian women, with 25% of global cervical cancer mortality occurring in India.
- Most cases are preventable through early HPV detection and vaccination.
About DBT-Led Initiative
- Launch & Development: Conceptualized under DBT in August 2021 to create a comprehensive, indigenous HPV screening solution tailored to India’s public health needs, in consultation with government bodies and sectoral regulators.
- Objective: Develop affordable, accurate diagnostic tools incorporating banking, investments, insurance, postal and pension sector learnings to enhance access, usage and quality of healthcare diagnostics.
- Collaborators: All India Institute of Medical Sciences (AIIMS) Delhi; National Institute of Cancer Prevention and Research (NICPR), Noida; National Institute for Research in Reproductive and Child Health (NIRRCH), Mumbai; WHO International Agency for Research on Cancer (IARC).
Significance of Kit
- Enhanced Accessibility: Point-of-care RT-PCR kits enable rapid screening in rural and resource-limited settings where laboratory access is constrained.
- Policy Alignment: Bolsters India’s mission to reduce cervical cancer incidence and mortality by meeting WHO’s 2030 screening targets (70% coverage).
- Economic Benefit: Lower per-test costs and simplified assay design facilitate scale-up in national screening programmes, potentially reducing the burden on tertiary care.
- Health Outcomes: Early HPV detection can intercept pre-cancerous changes, significantly improving survival rates and reducing the long-term healthcare load.